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"Liposomal Encapsulated Vitamin C in Complex Regional Pain Syndrome"

Primary Purpose

Complex Regional Pain Syndrome I of Lower Limb

Status

Completed

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

liposomal vitamin C

standard vitamin C

placebo

About this trial

This is an interventional prevention trial for Complex Regional Pain Syndrome I of Lower Limb

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Female, Age > 18 years
The woman of childbearing age - if applicable - must have a negative urine pregnancy test result and must agree to use adequate contraception (hormonal or barrier contraception method, or abstinence) during the study and one month later)
Consenting patient
Agrees to maintain the current level of physical activity throughout the study.
Agrees to avoid vitamins and supplements for 30 days before enrolment and during the study.
Avoid nutritious yeasts, whey protein, energy drinks, pomegranate, pomegranate juice, grapefruit, grapefruit juice and alcohol 7 days before enrolment and during the study
Willingness and ability to comply with scheduled visits, cellular phone calls, treatment plans, laboratory tests and completion of other study procedures specified in the protocol.

Exclusion Criteria:

Pregnant, breastfeeding or considering pregnancy during the trial
Diabetic women
No renal lithiasis
No deficiency Glucose-6-phosphate dehydrogenase
Unstable medical conditions
Immunocompromised persons such as subjects who have undergone organ transplantation
Subjects who planned surgery during the clinical study
History of blood disorders / bleeding
Alcohol abuse (> 2 standard alcoholic beverages per day) or drug addiction in the last 6 months
Participation in a clinical research trial within 30 days of randomization
Allergy or sensitivity to the product during the clinical study.
Persons who have a cognitive impairment and/or are unable to give an informed opinion.
Any other condition that, in the opinion of the physician, could affect the subject and lead to the successful completion of the study, action or pose a significant risk to the subject.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Allocated to conventional vitamin C (n= 22)

Allocated to liposomal vitamin C (n= 22)

Allocated to placebo (n= 22)

Arm Description

Received allocated conventional vitamin C (n= 22) Did not receive allocated conventional vitamin C (n= 0)

Received allocated liposomal vitamin C (n= 22) Did not receive allocated liposomal vitamin C (n= 0)

Received allocated intervention (n= 22) Did not receive allocated intervention (n= 0)

Outcomes

Primary Outcome Measures

Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity

We take an x-ray of the knee then we calculate of the Index of Caton and Deschamps AT / AP which must be close to 1 cm (from the upper edge to the lower edge of the patella which must be equal to the distance between the tip of the patella and anterior tibial tuberosity) to be interpreted as a transposed tuberosity.

Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones

Radiographs of the knee in monopodial support at 30° flexion (schuss) were taken. Measurement analysis of the translation of the tibia relative to the femur which must be close to 0 cm for the patient to be positive for the outcome.

Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis

Radiographs of the knee in Schuss with an external decoaptation which must be close to 0 cm and a pan gono gram standing from the front

Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis

X-rays of the knee and Schuss profile with an internal and external decoaptation which must be close to 0 cm with pan gonogram standing from the front (x-rays of the long axes of the pelvis of the ankles with measurement of the HKA axes on the prosthesis side and on the non-side operated which must be close to 180°) to have eccentric arthritis.

Secondary Outcome Measures

Full Information

NCT ID

NCT04204200

First Posted

December 13, 2019

Last Updated

January 31, 2020

Sponsor

Centre Hospitalier de Ham

1. Study Identification

Unique Protocol Identification Number

NCT04204200

Brief Title

"Liposomal Encapsulated Vitamin C in Complex Regional Pain Syndrome"

Official Title

Prevention of Complex Regional Pain Syndrome Using Liposomal Encapsulated Vitamin C in Programmed Knee Surgery; A Prospective Randomized Trial

Study Type

Interventional

2. Study Status

Record Verification Date

January 2020

Overall Recruitment Status

Completed

Study Start Date

January 6, 2014 (Actual)

Primary Completion Date

January 8, 2018 (Actual)

Study Completion Date

June 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Centre Hospitalier de Ham

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Abstract: Complex regional pain syndrome (CRPS) is a significant complication in operated osteoarticular pathology and may adversely affect patient's quality of life. Vitamin C is an anti-oxidant and a neuro-modulating agent. Intake of vitamin C appears to be the only preventative factor. The objective of this study seeks to assess the effectiveness of liposomal conditioning of vitamin-C in reducing CRPS and to show evidence that it is more effective than taking vitamin C in its usual form.

Detailed Description

Methods: Three series of patients undergone for identical pathologies the same surgery performed in the same centre by a single surgeon using the same operative techniques and the same implants. The first group took vitamin C in liposomal form. The second one took classical vitamin C tablets while the third one received placebo pills. Comparison was made between both groups which were identical in number and were the same average age. Results were compared and analysed at the end of one-year follow-up.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Complex Regional Pain Syndrome I of Lower Limb

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

66 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Allocated to conventional vitamin C (n= 22)

Arm Type

Active Comparator

Arm Description

Received allocated conventional vitamin C (n= 22) Did not receive allocated conventional vitamin C (n= 0)

Arm Title

Allocated to liposomal vitamin C (n= 22)

Arm Type

Active Comparator

Arm Description

Received allocated liposomal vitamin C (n= 22) Did not receive allocated liposomal vitamin C (n= 0)

Arm Title

Allocated to placebo (n= 22)

Arm Type

Placebo Comparator

Arm Description

Received allocated intervention (n= 22) Did not receive allocated intervention (n= 0)

Intervention Type

Dietary Supplement

Intervention Name(s)

liposomal vitamin C

Intervention Description

The intake of liposomal vitamin C at 500 mg, in the morning and evening, one week before surgery, one during the day of surgery and lastly, during the first 21 post operation days.

Intervention Type

Dietary Supplement

Intervention Name(s)

standard vitamin C

Intervention Description

The intake of traditional vitamin C with a daily intake of 500 mg in the morning and evening for 28 days (starting 7 days before the operative procedure, on the day of the surgery and ending twenty-one days after surgery).

Intervention Type

Dietary Supplement

Intervention Name(s)

placebo

Intervention Description

The intake placebo was taken daily in the morning and the evening for 28 days (7 days before surgery, on the day of surgery and twenty-one days after the surgical procedure).

Primary Outcome Measure Information:

Title

Number of Participants Operated for Complex Regional Pain Syndrome Who Had Transposition of Anterior Tibial Tuberosity

Description

Time Frame

After one-year of follow-up

Title

Number of Participants Operated for Complex Regional Pain Syndrome Who Had Ligamentoplasty ACL According to Kenneth-Jones

Description

Time Frame

After one-year follow-up

Title

Number of Participants Operated for Complex Regional Pain Syndrome Who Had Internal Unicompartmental Arthroplasty for Centralized Arthritis

Description

Radiographs of the knee in Schuss with an external decoaptation which must be close to 0 cm and a pan gono gram standing from the front

Time Frame

After one-year follow-up

Title

Number of Participants Operated for Complex Regional Pain Syndrome Who Had Total Knee Arthroplasty for Eccentric Arthritis

Description

Time Frame

After one-year follow-up

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Female, Age > 18 years The woman of childbearing age - if applicable - must have a negative urine pregnancy test result and must agree to use adequate contraception (hormonal or barrier contraception method, or abstinence) during the study and one month later) Consenting patient Agrees to maintain the current level of physical activity throughout the study. Agrees to avoid vitamins and supplements for 30 days before enrolment and during the study. Avoid nutritious yeasts, whey protein, energy drinks, pomegranate, pomegranate juice, grapefruit, grapefruit juice and alcohol 7 days before enrolment and during the study Willingness and ability to comply with scheduled visits, cellular phone calls, treatment plans, laboratory tests and completion of other study procedures specified in the protocol. Exclusion Criteria: Pregnant, breastfeeding or considering pregnancy during the trial Diabetic women No renal lithiasis No deficiency Glucose-6-phosphate dehydrogenase Unstable medical conditions Immunocompromised persons such as subjects who have undergone organ transplantation Subjects who planned surgery during the clinical study History of blood disorders / bleeding Alcohol abuse (> 2 standard alcoholic beverages per day) or drug addiction in the last 6 months Participation in a clinical research trial within 30 days of randomization Allergy or sensitivity to the product during the clinical study. Persons who have a cognitive impairment and/or are unable to give an informed opinion. Any other condition that, in the opinion of the physician, could affect the subject and lead to the successful completion of the study, action or pose a significant risk to the subject.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Time Frame

5 years

IPD Sharing Access Criteria

Information will be given after approval.

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"Liposomal Encapsulated Vitamin C in Complex Regional Pain Syndrome"

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